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Serious Rituximab candidate, targeting EMA approval in 2018, produced via an innovative and first in the world fully single-use process

"Single-use technologies are the perfect choice for biosimilar producers, since it allows us to lower the upfront investment, and foremost - stay flexible in order to adapt to the variable market needs."

- Dr. Slavomir Jaros- CSO of Mabion

Mabion (Lodz, Poland) has been founded in March 2007 by four domestic pharmaceutical companies, and became public with a successful IPO in 2010.

Mabion current main project is MabionCD20; Rituximab (biosimilar of Rituxan/Mabthera from Roche); under successfully running and one of the most advanced clinical phase III studies in Europe and positioned into the top 4 of the “Rituximab race”. Mabion is targeting a submission to EMA in 2016.

Mabion is starting operating a new cGMP manufacturing plant; with the target of producing several molecules in parallel in house developed in a “semi-continuous” mode.

With a complete innovative and single-use process; the project is ambitious. USP start with 2 x 2500 L orbital shacking single-use bioreactors, and the possibility to extend to four systems; semi-continuous DSP process, using state-of-the-art technologies such as Membrane chromatography for polishing step, flexible unit operations systems (FlexAct) and single use custom final filling line.

With a highly knowledgeable Mabion’s project team and with Sartorius Integrated Solutions Engineering capabilities for complete single-use processes, the project was successfully handled from conceptual design, basic design, through detailed design until project handover. The strict project timeline was met and allowed the integration of 3rd party equipment in the process platform, while enabling operators to guide single-use process unit operations via a SCADA system.

Dr. Slawomir Jaros, CSO, COO of Mabion

Until now, disposables were not used in commercial scales due to lack of big enough disposable bioreactors. Mabion has resolved that problem by constructing together with a partner bioreactor company single-use bioreactor that has working volume of 2500 L. Successful development and implementation of mentioned technology triggered possibility of an investment in fully disposable downstream line. With the highly professional Sartorius project management team, we were able to set-up in record time the 1st such a scale single-use manufacturing process transfer from our current pilot scale. This will be the driver to provide safe, high quality and economically competitive drug to treat Rheumatoid Arthritis, Non Hodgkin’s Lymphoma and Leukemia in Europe...at first!

Mabion is targeting a submission to EMA in 2016 and is planning to work further with Sartorius team in order to identify process spaces for use of upcoming disposable solutions in the future for next products in pipeline.

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